ABSTRACT
A. Regardless of whether a contract originates with the Sponsor or Contract Research Organization (CRO) or with Company, the Investigator, Research Director, and Legal Department will review the contract to ensure it contains: l . Sponsor's name and address 2. CRO's name and address, if applicable 3. Protocol title and number 4. Indemnification language 5. Confidentiality agreement (if not in a separate document) 6. Estimated start and finish dates 7. Estimated number of subjects expected to enrol1 from this site 8. Budget information and payment schedule, including terms for delays and
termination of the study 9. The definition of a "completed" subject (i.e., fully paid) 10. Description of reimbursement for study subjects who experience an adverse event
or who are injured while participating in the study l l . A list of the responsibilities assigned to the study site 12. A statement of whose Standard Operating Procedures will be followed (i.e., the
Sponsor, CRO, or site's) 1 3. Publication rights 14. Data ownership rights
B. All Investigator Agreements must be approved by the Legal Department, a representative of Company, and the Investigator.
